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RECRUITING Phase 2 ClinicalTrials.gov

A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression

Sponsor: Draig Therapeutics Ltd • ClinicalTrials.gov ID: NCT07610473

Registry updated: 2026-10-14
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Description

In this study, researchers will learn more about a study drug called DT-101 in participants with Major Depressive Disorder (MDD), a form of depression. The goal of this clinical trial is to learn if DT-101 can treat depression in adults. The effect of DT-101 will be compared to placebo. A placebo looks the drug but contains no medicine. Subjects will attend the clinic for complete general health checks and to complete questionnaires.

Interventions

  • DT-101 (Drug)
    DT-101
  • Placebo (Drug)
    Placebo

Eligibility criteria

Inclusion Criteria: * The participant is able to read, understand and communicate in the local language used at the study site, and is willing to provide written informed consent * Male or female (assigned at birth, inclusive of all gender identities) participant must be 18 to 75 years of age, inclusive at the time of signing the informed consent. * Has recurrent depression (defined as at least one prior episode excluding the current one), as diagnosed by DSM 5-TR (Diagnostic and Statistical Manual of Mental Disorders, 2022). Exclusion Criteria: * Pregnant or breastfeeding or plans to become pregnant during the study. * Unstable medical condition or unstable chronic disease. * Significant neurological abnormality. * History of moderate or severe alcohol or drug use disorder as per DSM-5-TR in the 6 months prior to Screening. * History of seizure. * In the investigator's opinion, the participant is not capable of adhering to the protocol requirements.

Conditions

Major Depressive Disorder (MDD)

Locations

  • Draig Clinical Site — Phoenix, Arizona, United States
  • Draig Clinical Site — Little Rock, Arkansas, United States
  • Draig Clinical Site — Bellflower, California, United States
  • Draig Clinical Site — Costa Mesa, California, United States
  • Draig Clinical Site — Lafayette, California, United States
  • Draig Clinical Site — Hialeah, Florida, United States
  • Draig Clinical Site — Orlando, Florida, United States
  • Draig Clinical Site — Orlando, Florida, United States
  • Draig Clinical Site — Tampa, Florida, United States
  • Draig Clinical Site — Tampa, Florida, United States
  • Draig Clinical Site — Decatur, Georgia, United States
  • Draig Clinical Site — Chicago, Illinois, United States
  • Draig Clinical Site — Skokie, Illinois, United States
  • Draig Clinical Site — Boston, Massachusetts, United States
  • Draig Clinical Site — New York, New York, United States
  • Draig Clinical Site — New York, New York, United States
  • Draig Clinical Site — Columbus, Ohio, United States
  • Draig Clinical Site — Allentown, Pennsylvania, United States
  • Draig Clinical Site — Media, Pennsylvania, United States
  • Draig Clinical Site — DeSoto, Texas, United States
  • Draig Clinical Site — Fort Worth, Texas, United States
  • Draig Clinical Site — Bellevue, Washington, United States
  • Draig Clinical Site — Seattle, Washington, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record